Study of Circulating Tumor DNA (ctDNA) Kinetics in Immuno-oncology (IO-KIN)

Completed

• Conditions: HNSCC; Head and Neck Cancer; Squamous Cell Carcinoma; Advanced Cancer; Metastatic Cancer

• Registration Number: NCT04606940
• Lead Sponsor: University Health Network, Toronto

Brief Summary

This study aims to study the kinetics of ctDNA levels after the first dose of immune checkpoint inhibitor in patients with recurrent or metastatic head and neck cancer. This is an important study to understand the optimal timing for ctDNA quantitation for future studies in immunotherapy, though further validation would be needed in other tumor types. It may help standardize the most relevant blood collection time points so that patients will not be subjected to multiple blood draws at random time points in future liquid biopsy trials.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-18
• Study Start: 2020-10-19
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-28
• Primary Completion: 2021-10-12
• Study Completion: 2021-10-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Histologically or cytological confirmed recurrent, metastatic or advanced HNSCC of the oral cavity, oropharynx, hypopharynx, larynx or unknown origin (but being treated as HNSCC).
• Availability of tumor sample.
• Patients who are going to receive at least one dose of anti-PD1antibody (nivolumab or pembrolizumab).

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Exclusion Criteria

• Nasopharynx, maxillary sinus, nasal/nasal vestibule squamous tumors
• Patients who are receiving concomitantly any other tumor-specific treatment (chemotherapy, radiotherapy, any monoclonal antibodies different from anti- PD-1 antibodies).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in kinetics of ctDNA changes in advanced/metastatic will be measured for HNSCC patients treated with immune checkpoint inhibitors (anti-PD-1 antibody).	Through study completion, up to 1.5 years	At each time-point, absolute ctDNA levels will be calculated from all test targets (including undetected targets).The change in ctDNA from baseline to every time-point is defined as the percentage change in absolute ctDNA levels in plasma at that end point since baseline.

Secondary Outcome Measures

Name	Time	Method
The changes in ctDNA levels will be measured. These value will help correlate with progression free survival (PFS) and overall survival (OS).	Through study completion, up to 1.5 years	At each time-point, absolute ctDNA levels will be calculated from all test targets (including undetected targets).The change in ctDNA from baseline to every time-point is defined as the percentage change in absolute ctDNA levels in plasma at that end point since baseline.
The optimal time-point will be measured to analyze ctDNA as a predictive marker of response to immune checkpoint inhibitors (anti-PD-1 antibody).	Through study completion, up to 1.5 years	At each time-point, absolute ctDNA levels will be calculated from all test targets (including undetected targets).The change in ctDNA from baseline to every time-point is defined as the percentage change in absolute ctDNA levels in plasma at that end point since baseline.

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada